The Effect of BOSU Ball Balance Exercises Added to Complete Decongestive Treatment on Static and Dynamic Balance in Breast Cancer-associated Lymphedema.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Static balance measurements
研究概览
简要总结
The aim of the study is to investigate the effect of balance exercises performed with the BOSU ball added to complete decongestive treatment on static and dynamic balance in patients with breast cancer-related lymphedema.
详细描述
The study was planned as a randomized controlled study. The patients who had unilateral breast cancer-associated lymphedema according to the 2020 diagnostic criteria of the International Society of Lymphology for at least six months and met the inclusion and exclusion criteria will be randomly divided into 2 groups.
The trial will be carried out at Pamukkale University Department of Physical Medicine and Rehabilitation PAUTERM between December 2023 and June 2025. The local ethics committee approved the study. All women will be informed about the purpose and content of the study and all women will sign written consent to participate in the study.
Group1: Group receiving balance exercise with BOSU Ball added to complete decongestive treatment (Intervention group) Complete decongestive treatment program consists of manual lymph drainage, multi-layer bandaging, skin/nail care and exercise treatments. The treatment will last 45 minutes/session, 5 sessions/week and 3 weeks. Patients in the intervention group will also receive balance exercises with a BOSU ball. These exercises will be performed in 2 sets, 5 days a week for 3 weeks. Each set will last 15 minutes. It will take 15 sessions in total. These exercises include 10 balance exercise movements performed on a bosu ball.
Group 2: Group receiving complete decongestive treatment (Active control group) Patients in this group will receive only a complete decongestive treatment program consisting manual lymph drainage, multilayer bandaging, skin/nail care, and exercise treatments. The treatment will last 45 minutes/session, 5 sessions/week and 3 weeks.
All patients will be evaluated with the following evaluation parameters before the treatment and at the time of discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female gender
- •Patients aged 18-65 years
- •Having a history of unilateral mastectomy and lymph node dissection at least one year ago due to breast cancer diagnosis.
- •Having unilateral breast cancer-related upper extremity lymphedema (>20% volume difference between the two upper extremities) according to the diagnostic criteria of the - International Society of Lymphology (Committee 2020) for at least six months.
- •Not having received lymphedema treatment or exercise therapy for the last six months
- •Completing breast cancer primary treatment at least 6 months ago (except hormone therapy/aromatase inhibitors)
排除标准
- •Bilateral breast cancer
- •Bilateral axillary lymph node dissection
- •Metastatic breast cancer
- •Receiving ongoing radiotherapy or chemotherapy
- •Primary or bilateral lymphedema
- •Having active cancer
- •Presence of stage 3 lymphedema
- •Uncontrolled serious systemic disease (cardiopulmonary diseases, arterial or venous diseases, renal dysfunction, uncontrolled hypertension or hypotension).
- •Active or previous infection in the last 3 months (cellulitis, lymphangitis)
- •Presence of open wounds
- •Having any problems that may affect balance (vestibular, visual, neurological or orthopedic diseases)
- •Using medications that may affect body fluid and electrolyte balance (diuretics, etc.).
- •Individuals with serious mental and sensory problems
- •History of spine surgery in the last 6 months
- •Being pregnant
- •Body mass index >40 kg/m2
结局指标
主要结局
Static balance measurements
时间窗: 3 weeks after the start of rehabilitation
The TecnoBody Prokin 252 system was used to assess balance in the standing position for all participants. This equipment provides data on the center of pressure path length and the area over which the center of pressure moves. Smaller values indicate greater stability and balance ability in the lower extremities.
Dynamic balance measurements
时间窗: 3 weeks after the start of rehabilitation
The TecnoBody Prokin 252 system was used to assess balance in the standing position for all participants. This equipment provides data on the average track error and stability index.
次要结局
- Timed Up and Go Test(3 weeks after the start of rehabilitation)
- Arm circumference measurements(3 weeks after the start of rehabilitation)
- Fullerton Advanced Balance Scale(3 weeks after the start of rehabilitation)
- Arm volumetric measurements(3 weeks after the start of rehabilitation)
- Quality of Life Measurement ULL-27(3 weeks after the start of rehabilitation)
- Fall Activity Scale(3 weeks after the start of rehabilitation)
- Tampa Kinesiophobia Scale(3 weeks after the start of rehabilitation)
- Hospital Anxiety and Depression Scale(3 weeks after the start of rehabilitation)
研究者
Oya Topuz
Clinical Professor
Pamukkale University